FindTrial
Sign In

This is a study to assess the safety and immune (antibody) response of a CSL inactivated influenza virus vaccine in a healthy paediatric, adult and senior adult populations.

An Observer-Blind, Randomized, Comparator-Controlled, Single-Centre Study to Evaluate the Tolerability, Safety, and Immunogenicity of Inactivated Influenza Vaccine, CSL Limited in a Healthy Pediatrics and Adult Population (aged =>3 years to =< 80 years)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-000177-12-Outside-EU/EEA
Enrollment
720
Registered
2015-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, human

Interventions

Trade Name: CSL inactivated influenza virus vaccine Product Name: CSL inactivated influenza virus vaccine (NH strains 2006/2007 season) Pharmaceutical Form: Suspension for injection in pre-filled syr

Sponsors

CSL Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy subjects aged =>3 years to ==65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: Hypersensitivity to eggs, chicken protein, neomycin, polymyxin or any components of the vaccine. Influenza vaccination in the previous 6 months. Clinical signs of active infection and/or an axillary temperature of =>37.1°C at study entry. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving Study Vaccine.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety of CSL Inactivated Influenza Virus Vaccine in a healthy paediatric, adult and senior adult population (=>3 years to =3 years to =< 80 years of age).;Primary end point(s): The frequency and intensity of local and systemic adverse reactions of participants within 72 hours post vaccination. Collection of any adverse events of participants within 28 days post vaccination; assessment of incidence rate of adverse events and relationship with vaccine injection.;Timepoint(s) of evaluation of this end point: Up to 72 hours after vaccination.   28 days after vaccination.—

Secondary

MeasureTime frame
Secondary end point(s): The proportion of participants achieving seroconversion after vaccination. The proportion of participants achieving seroprotection after vaccination. Determination of the geometric mean fold increase (GMFI) of the HI antibody titre after vaccination.;Timepoint(s) of evaluation of this end point: 21 days after vaccination.—

Countries

China

Contacts

Public ContactClinical Program Director

bioCSL Pty Ltd

biocsl.clinicaltrials@biocsl.com.au

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026